The following Document contains the specifications that are developed for submitting animal and human study datasets in electronic format. Datasets are views of the study data used by reviewers to conduct specific analyses of the study data. They may include both raw and derived data. Because of the unpredictability of the scientific review process, it is impossible to enumerate a priori all datasets needed for review. Prior to the submission, you should discuss with the review division the datasets that should be provided, the data elements that should be included in each dataset, and the organization of the data within the file. Additionally, not all FDA centers have adopted all aspects of these specifications; sponsors are advised to discuss with the reviewing division data needs prior to preparing data for submission.